Testing HRS-6208 for patients with advanced solid tumors
A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HRS-6208 Monotherapy in Patients With Advanced Solid Tumors
This study is testing a new treatment called HRS-6208 to see if it is safe and helps people with advanced solid tumors that can't be treated with standard options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06727812 on ClinicalTrials.gov |
What this trial studies
This open, multicenter Phase I study aims to evaluate the safety and tolerability of HRS-6208 in patients suffering from advanced solid tumors. The trial will enroll patients who have unresectable locally advanced or metastatic solid tumors that have either relapsed after standard treatments or have no available standard treatment options. Participants will be monitored for adverse effects and overall response to the treatment. The study will follow strict eligibility criteria to ensure the safety of participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors that are not amenable to surgery and have progressed after standard treatments.
Not a fit: Patients with a history of other malignancies within the past 5 years or those with severe cardiovascular or cerebrovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is part of ongoing research in cancer treatment, the specific use of HRS-6208 in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology who have relapsed or progressed after standard treatment, or have no standard treatment options, or do not apply standard treatment at this stage; 2. Age 18\~75 years old; 3. At least one measurable lesion per RECIST v1.1 criteria; 4. ECOG PS score: 0-1. Exclusion Criteria: 1. History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. The adverse reactions of previous anti-tumor therapy have not recovered to NCI-CTCAE v5.0 grade evaluation ≤ 1; 3. He has severe cardiovascular and cerebrovascular diseases; 4. Severe infection within 4 weeks prior to the first dose.
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Xin Xu
- Email: xin.xu@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.